Using the ICH Q8 Design Space for ICH Q12 Lifecycle Knowledge Management

by Mark F. Witcher, PhD
Volume 15, Issue 4 (Winter 2016/2017)

One of the objectives of the upcoming ICH 12: Pharmaceutical Lifecycle Management guidance is to manage product development and manufacturing process information in order to establish and maintain appropriate change control over the entire product lifecycle. The 2014 ICH Q12 Concept Paper also stresses ICH Q12’s role in connecting ICH Q8 through ICH Q11 into a complete lifecycle approach to assure product quality and continuous improvement of manufacturing operations. However, neither the Concept Paper or subsequent public discussion and presentations appear to identify the ICH Q8 design space as a central mechanism for collecting and maintaining product and process information...

Witcher MF. Using the ICH Q8 design space for ICH Q12 lifecycle knowledge management. BioProcess J, 2017; 15(4): 7. https://doi.org/10.12665/J154.Witcher.U.

Posted online February 15, 2017.